Epilepsy is among the most common neurological disorders, affecting more than 50 million people worldwide. Antiseizure medications are the first-line intervention, but approximately one-third of patients do not respond sufficiently to drug treatments. For these individuals and for people who cannot tolerate drug-induced side effects, treatment options have so far been limited to invasive surgery, experimental procedures, and diet and lifestyle supports. Many patients with drug-resistant epilepsy (DRE) continue to experience seizures on an ongoing basis, negatively impacting their quality of life, physical safety and mental health.
A minimally invasive brain stimulation system now offers these patients new hope. IDE‑approved for a pivotal clinical trial in the United States and commercially available in six European countries, EASEE® (Epicranial Application of Stimulation Electrodes for Epilepsy), developed by PRECISIS GmbH, uses a thin electrode placed under the scalp, on top of the skull bone to deliver targeted electrical pulses to the brain region where seizures originate. The implantation procedure does not require opening the skull. Instead, the implant sits on the skull bone without touching the brain and remains invisible beneath the skin, making the procedure much faster, simpler and lower‑risk than traditional neurosurgical treatments for focal epilepsy.
Expanding the Treatment Landscape for Focal Epilepsy
One of the core components of the EASEE® device is the battery-powered Implantable Pulse Generator (IPG), comprising energy-efficient and reliable electronic parts from Infineon Technologies that help provide processing, data storage and the ability to deliver precisely targeted, patient-specific electrical stimulation to the focal area.
Data and device security were key considerations during the development, Michael Tittelbach, CTO and Managing Director of PRECISIS GmbH, explains. “When patients are living with a device inside them that delivers neurostimulation treatment to treat severe diseases like epilepsy, it is of the utmost importance that no third party or cybercriminal would ever be able to gain control of that device. In healthcare, we are entrusted with protecting patients’ private health information, and we take that responsibility very seriously. Just as we pride ourselves on developing innovative solutions that help to protect their health.”
Meeting Real-World Patient Needs through Innovation
The unique epicranial placement of the EASEE® electrode lowers the surgical risks for patients compared to other neurostimulation procedures, which are much more invasive and require direct surgical access to the brain. Unlike traditional epilepsy surgery, there is no risk of damaging brain tissue. The procedure is relatively simple for physicians to learn, so treating neurosurgeons quickly become competent in implanting EASEE®. As stimulation is personalized and set below the individual perception threshold, patients can continue their daily lives without noticing it.
Clinical studies have demonstrated both the safety and effectiveness of EASEE® in reducing the seizure burden for patients. Clinical trial data demonstrated a median seizure frequency reduction of 68% after two years of treatment, with four out of every five patients using EASEE® choosing to continue the therapy. Furthermore, at the two-year follow-up, almost two-thirds of patients benefited from the treatment, experiencing fewer than half the seizures as prior to EASEE®. No serious adverse events related to the procedure or device were reported in the trials, highlighting the positive safety profile of the implantation and the limited side effects of stimulation.
EASEE® is already driving significant advances in patient care and improvements in quality of life. “As soon as they are diagnosed with drug-resistant focal epilepsy, patients can discuss with their treating neurologists if EASEE® is an option for them,” says Tittelbach. “This novel stimulation method has shown good efficacy, with low risks involved. If it doesn’t work for a particular patient, the device can easily be removed, and all the other, more invasive treatment options are still on the table. It makes sense for this approach to become the first-choice treatment for focal DRE.”
Transforming the Lives of Patients
Living with drug‑resistant focal epilepsy can be incredibly challenging, impacting both the physical safety and mental well‑being of those affected. Ibrahim, a patient, says that seizures—and the fear of seizures—had taken away his independence and shattered his daily routines.
“Before I received EASEE®, my daily life was extremely limited,” he explains. “I was severely depressed and spent most of my time alone in my room. Everyday activities like meeting friends, going outside or spending time with my family were hardly possible. The strong side effects of the medications gave me physical problems and made me aggressive, so that my family had to arrange 24-hour care for me. After seizures, I was often unable to function for an entire day.”
EASEE® dramatically changed every aspect of Ibrahim’s life. “My life today cannot be compared to what it was before. My family feels like a different person—my old self—came back to them after the surgery. I feel like I am alive again. I can manage my daily routine independently, no one needs to take care of me or constantly watch over me, and I can participate in life again. Before the procedure, I had dark thoughts and no idea how to keep going. Today, I have joy in life and hope for the future again.”
“I simply cannot thank the entire PRECISIS team enough,” he adds. “I am incredibly grateful that there are people with vision who believe in miracles. And I am grateful that my neurologist believed so strongly in this treatment. His confidence transferred to me and gave me hope.”
Partnering to Reshape the Future of Medical Care
PRECISIS joined forces with Infineon Technologies for the development of the next-generation device. The collaboration has been very fruitful, with the parties bringing their respective expertise in medical innovation and advanced semiconductor technology to create a secure, energy-efficient solution that may revolutionize the treatment of neurological disorders.
“We are already working on the next iteration of our technology,” says Tittelbach. “In the future, the device will both stimulate and sense. The electrode array will collect data that will help us control and improve upon how it delivers electrical stimulation. To do this, we’ll use AI and edge computing to monitor the device’s data output continuously.”
To learn more about PRECISIS and EASEE®, go here.
